Cancer Approvals
正文 · 中文译文
癌症批准 肿瘤（癌症）/血液系统恶性肿瘤批准通知 进行中 | 癌症加速批准 已验证临床获益 | 癌症加速批准 已撤回 | 癌症加速批准 其他 | 癌症加速批准 FDA的肿瘤监管格局涵盖已批准疗法、正在进行的调查研究、已验证的加速批准以及已撤回的适应证。通过其卓越肿瘤中心（OCE）和加速批准计划，FDA持续扩大对创新癌症治疗的可及性——包括靶向治疗、抗体偶联药物和免疫疗法——同时维持严格的上市后监管。当确证性试验验证临床获益时，加速批准转为常规批准；当未能验证时，这些适应证即被撤回。 子主题段落 更多关于癌症批准 肿瘤（癌症）/血液系统恶性肿瘤批准通知
正文 · 英文原文
Cancer Approvals Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals The FDA's oncology regulatory landscape spans approved therapies, ongoing investigational studies, verified accelerated approvals, and withdrawn indications. Through its Oncology Center of Excellence (OCE) and the Accelerated Approval Program, the FDA continues to expand access to innovative cancer treatments — including targeted therapies, antibody-drug conjugates, and immunotherapies — while maintaining rigorous post-market oversight. When confirmatory trials verify clinical benefit, accelerated approvals are converted to regular approvals; when they do not, those indications are withdrawn. Sub-Topic Paragraphs More On Cancer Approvals Oncology (Cancer)/Hematologic Malignancies Approval Notifications
摘要 待译
Accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials for ongoing clinical trial(s), verified clinical benefit and withdrawn.